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International Group To Create Clinical Trial Registry Guidelines
On May 23, Brown University professor Kay Dickersin will join a group of international health policy experts in Portland, Ore., to create a blueprint for a global clinical trials registry. Controversy over the effects of antidepressants in children has sparked a move toward registration of drug trials, which could help ensure that research results are complete, accurate and publicly available.
PROVIDENCE, R.I. — Kay Dickersin, a clinical trials expert and Brown University professor, will join nearly 100 health experts in Portland, Ore., on Monday, May 23, 2005, to decide how best to build a worldwide clinical trials registry.
Dickersin is a leader of the Ottawa Group, an ad-hoc assembly of government, academic and medical experts from 17 countries advocating for public registration of all human clinical trials. The group gathered in October 2004 at a meeting hosted by the Canadian Institutes of Health Research and drafted the Ottawa Statement, which calls for full trial disclosure on ethical and scientific grounds. The statement was published April 21, 2005, in the British Medical Journal.
Such support for trial registration is growing. After previously undisclosed risks of antidepressants and COX-2 inhibitors came to light last year, consumer groups, politicians, medical journal editors and others have endorsed mandatory disclosure of safety and efficacy results.
“There is broad agreement that clinical trial registries will better protect the public and improve medical treatment,” Dickersin said. “But what should they look like? What data should they include? Who has access? When? The Ottawa Group begins that discussion in Portland.”
During the annual meeting of the Society for Clinical Trials, members of the group will discuss how to put into action its shared principles. These include registering all types of human trials, reporting published and unpublished results, and providing free public access to the data.
Dickersin said the goal of creating the registry blueprint is to influence public policy. This year, a bill that would mandate public disclosure of results from new prescription drug trials was introduced in the U.S. Senate. The World Health Organization is developing plans for a global registry, and has used the Ottawa Statement in its deliberations. To learn more about the Ottawa Group, visit http://ottawagroup.ohri.ca/index.html
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